This is what it’s all about

Truthman30 made a comment on one of my recent posts …Let’s get Paxil out of mouths and into the garbage, that’s where it belongs…

I think he’s hit the nail on the head

“The thing is , it should never have been licenced…

I have long been calling Seroxat the mental health thalidomide, even before the recent indications of Seroxat inducing malformations in new-borns I had thought of it as such. But, I wasn’t prepared for the absolute shock and horror I experienced when I read the news last year about these poor babies being harmed by this defective and toxic medication. It is an absolute and total disgrace, and GSK should be paying for Public Health Adverts on TV and full page adverts in every newspaper and magazine alerting everybody about this. It is another thalidomide and I wonder for how long will the governments and mainstream media continue to ignore the facts of this disgusting assault on human life. I suspect this ignorance is down to a fear of losing advertising revenue and for MP’s it is a fear of losing jobs in their constituencies but surely, there are people brave enough to challenge this? This madness has to stop.

GSK spend millions every week promoting their bogus drugs but they don’t seem to care when their drugs do harm. Instead they play down the horrific consequences and still even in the face of undeniable proof of harm, and stacks of evidence, they continue to deny the truth. The Seroxat Scandal and its legacy is beyond reason, and it stems from a system which has been gorging itself on “Greed” for far too long. And it is a system which has rotted itself to death. It is deeply flawed and it has failed. This has to change.

It is beyond belief enough that Seroxat was still allowed a licence after the evidence of its increased risk of suicide and aggression in children and adults. But how in the name of god can anyone argue its “benefits” now considering the damage it is causing to these babies.

I would not have believed the stuff I have read about Seroxat before I started to investigate it. But, unfortunately the Seroxat Scandal is all too real and people’s lives have been destroyed because of corruption, opportunism and a complete lack of respect for human life and dignity from all of the parties involved. The Seroxat story is not just a mental health catastrophe of epic proportions; it is an assault and an abuse of human rights. It is a chemical holocaust.

The Scandal that is Seroxat brings every societal structure into question. From the patient groups funded by pharmas , to the GPs taking perks from Pharmas to promote and endorse drugs , to the drug reps encouraged to lie about side effects. And Not only does it have huge implications for the medical and pharma community, it also highlights the failure of drug regulation because of a pharma funded system which the government is responsible for, a Government which seems intent on protecting the interests of Big Business before the health of the public.

It also begs us to question the ethos and doctrine of biological psychiatry which has spawned into a multi billion-dollar industry itself because of its all too eager collusion with the drug companies. And because of the fraud and crimes of biological psychiatry, the “mentally ill” have been further stigmatized, alienated, murdered, maimed and harmed.

“Mental illness” has become bastardised, bought, sold and squandered and the profits from this bastardisation have been soaked in misery, blood and tears from the patients who have been the innocent victims of this rancid regime.

We can forget the word “patient”; the public are merely marketing “targets” in this system dominated by an insatiable and blatant greed. We can forget the word “victim” and replace it with “statistic”, because at the end of the day, it is profits, stocks and shares, which are valued before life, health and well being. We can forget also the word “medicine”, it no longer means a “remedy” for a “malady”, “Medicine” means “product”… And the sick patient in need of healing has been replaced with ” a consumer in need of a brand of a drug”.

This may be a cynical world and I admit after being exposed to Seroxat and all that has subsequently entailed, I have become a cynic myself but I urge anyone involved in promoting Seroxat to question their conscience and to read about the Seroxat induced malformations in new-borns and I urge them also to question their integrity as human beings. I do hope that this madness fuelled by greed can be conquered by the compassion which every human being is capable of but beyond that.. I really don’t know.”

http://seroxatkillsbabies.wordpress.com/

The good works of the Diabetes Monitoring Forum

I’ve just found this news item on the internet about the Diabetes Monitoring Forum and one of its early successes. It seems that the DMF developed important new patient guidelines in the form of an advice card.

New Patient Guidelines Developed to Help Prevent Deaths From Diabetic Ketoacidosis
Diabetic ketoacidosis (DKA), a complication of diabetes resulting from insufficient insulin, can lead to coma and eventually death if it is not controlled. Minimising the likelihood of developing DKA is the first priority for the newly set up Diabetes Monitoring Forum, which has created new blood ketone monitoring advice for patients.

Today at the annual Professional Conference of Diabetes UK in Glasgow the Forum presented the evidence-base supporting the development of this new advice card.

The catalyst for the card’s creation stems from a recent advance in monitoring technology, which enables patients to measure both blood glucose and blood ketones using the same device.

The new advice card was necessitated (is this really a word?) by a recent advance, whereby people with diabetes can now monitor blood ketones, with a meter that measures both blood glucose and blood ketones, the Optium Meter from MediSense, a division of Abbott Laboratories.

The new advice card, which will be made available through the healthcare team and launched later this year, provides a simple set of instructions for people with diabetes. It helps them to adjust their treatment according to the level of blood ketones detected by their monitor. Previously, the only way for people to keep a check on diabetic ketoacidosis was by measuring urinary ketones.

Read on here for more information about the new patient guidelines developed by the DMF, which I think I should point out is not an advert for the new Optium Meter from MediSense, a division of Abbott Laboratories. No really, it isn’t…

As for the DMF “…part of the overall mission of the Diabetes Monitoring Forum, which is to optimise the role of blood glucose and blood ketone monitoring in the management of diabetes. The Forum aims to achieve this by creating and evaluating advice and practical materials for both people with diabetes and healthcare professionals.”

To find out more you were asked to contact Dr Neil Bindemann at PRiMED Communications (PRiMED changed its name to Innervate on 16 March 2004).

All in all, I think it’s apposite to finish once again with the immortal words of Jim Thomson “… ask yourself one question…What does this person, or this organisation, have to gain from taking this position? All may become marginally clearer. Jim.”

More Astroturfing?

Remember what Jim Thomson wrote recently “… ask yourself one question…What does this person, or this organisation, have to gain from taking this position? All may become marginally clearer. Jim.”

I’d like you to hold that thought while we look at some facts about the The Diabetes Monitoring Forum (DMF), an organisation set up (and run?) by Innervate – “Making Connections in Healthcare”

You remember Innervate, I’m sure, Jim Thomson used to be Business Development Director with them, although he plays down his time there, telling us “Nor do I work for Innervate. I did for a short time, while I was trying to establish the Centre for Mental Health.” More on this particular issue another time, but for the moment I’m glad Jim’s cleared things up for us.

Back to the DMF – on its website, we are told:
“The Diabetes Monitoring Forum (DMF) is a group of diabetes healthcare professionals who came together with the aim of helping people with diabetes better understand the role of blood glucose and ketone monitoring in diabetes management.”

However, on the Innervate website we are told:
“The Diabetes Monitoring Forum, is a multidisciplinary group of healthcare professionals. The group was brought together by Innervate to develop practical education material that offers simple advice on appropriate blood glucose monitoring and blood ketone monitoring for people with diabetes. The DMF, with the help of Innervate, has more recently run a number of PCT workshops providing further support on blood glucose monitoring to primary care professionals.”

Spot the subtle but important difference?

Now, The sponsor of the DMF is Abbott Laboratories.

Abbott Diabetes Care was established in April 2004 after the acquisition of TheraSense™ Inc adding to the Abbott Laboratories company portfolio, which already included MediSense®. Abbott Laboratories is one of the largest and most innovative diagnostic companies in the world, with a presence in more than 130 countries.

Abbott Diabetes Care develops, manufactures and markets blood glucose monitoring systems that enable people with diabetes to manage their condition more effectively. Abbott Diabetes Care believes that the convenience and simplicity of its products promotes increased compliance by individuals with diabetes and provides more effective management of their condition. The convenience and simplicity of the blood glucose meters is illustrated in the product information sections of abbottdiabetescare.co.uk.

I wonder if Abbott is a client of Innervate’s?

I think the only way to finish off this post is with those wise words of Jim Thomson: “… ask yourself one question…What does this person, or this organisation, have to gain from taking this position? All may become marginally clearer. Jim.”

It’s all going wrong for Jean-Pierre Garnier at Glaxo

As Chief Executives go, JP Garnier has always been VERY well paid. But in order to justify his huge salary JP needs to deliver – and he’s not – in fact, he is fast becoming an embarrassment to the company. When Garnier said “I’ll be a hero in three years.” (5 May 2004), I’m not quite sure this is what he had in mind!

At Glaxo’s AGM last week shareholders voiced their anger over the poor performance of GSK’s share price, which has dropped by almost 15% over the past year.

GSK investor John Farmer blasted the group for its “colossal under-performance” and demanded the resignation of chairman Sir Christopher Gent and a more speedy exit for CEO Jean-Pierre Garnier. Garnier is not due to step down until May 2008.

The current controversy over Avandia, the latest in a long line of scandals associated with Glaxo and its drugs, has seen more than £9 billion wiped off the share price.

New data that shows Avandia dramatically increases the risk of heart attacks, has seen frightened patients abandoning a long-term trial of the drug that is aimed at proving its safety. Glaxo has become so alarmed at the threat to the 4,400-patient safety study that it is examining ways to persuade volunteers to stick with the drug.

Perhaps Glaxo could get Sir Christopher to write to all the patients and tell them what he told the AGM “We remain confident that the significant benefits of the medicine continue to outweigh any treatment risks.”

Yep, that should do it…

Or maybe a word from JP himself would help all Glaxo’s frightened patients: “If anyone thought drugs were without side-effects, hopefully that’s over. All drugs have side-effects. We are having to spend hundreds of millions of dollars on lawyers.” Jean-Pierre Garnier 23 April 2005

Glaxo share price down further still as Avandia prescriptions reach… ZERO

It’s not looking good for Glaxo as prescriptions for Avandia reach… a bit fat ZERO.

Glaxo Avandia Prescriptions Fall, Deutsche Bank Says –
writes Andrea Gerlin at Bloomberg May 29

Avandia’s share of new oral diabetes prescriptions fell to about zero from 10 percent in the two days after the May 21 report in the New England Journal of Medicine, Deutsche Bank analysts wrote in a note. Takeda Pharmaceutical Co.’s diabetes drug Actos’ share climbed to 22 percent from 10 percent, the analysts wrote, citing data from market research firm Impact Rx.

“This reaction is far worse than we had anticipated and suggests that there could be as much as 22 percent downside risk to GSK’s near-term earnings, suggesting that there is still further downside to GSK’s share price,” the analysts wrote.

The publication of the Cleveland Clinic study caused Glaxo shares to decline 9 percent last week, cutting $13.7 billion from the company’s market value. The stock fell 24 pence, or 1.8 percent, to 1,310 pence at 2:36 p.m. in London.

The New England Journal article said users of Avandia, the London-based drugmaker’s second-best-selling medicine, were 43 percent more likely to have a heart attack and had a 64 percent increase in the risk of death than those given other drugs.

Charities and their good works – a final statement

So it seems that I am not going to be able to discuss specifics about Jim Thomson’s work at Depression Alliance with him.

We now have his final statement on all related matters which can be read over at Seroxat Sufferers, along with details of some of the conversations between Jim and Bob Fiddaman.

Jim’s statement ends:
“I wish the readers of this blog nothing but the best – and in particular I wish you all good health. Above all, I ask you all to do this one thing. When you see or hear anything in this context, ask yourself one question…”What does this person, or this organisation, have to gain from taking this position?” All may become marginally clearer. Jim”.

All I can do is to echo Jim’s words and support this particular sentiment – “…ask yourself one question… What does this person, or this organisation, have to gain from taking this position?”

Ironically, that was how all this started for me – charities-web.pdf

However, for things to become REALLY clear, I think you must also ask “and who funds this person or organisation?”

Up to 100,000 heart attacks might be linked to Glaxo drug

This from the Washington Post last Friday (thanks to Truthman30 for the link):

FDA Study Said to Show Avandia Risk
By MARILYNN MARCHIONE

The government’s own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.

In a floor statement placed in the Senate record, Sen. Charles Grassley also said that safety watchdogs within the federal Food and Drug Administration “several months ago” recommended a “black box” on the drug’s label – the strongest possible warning.

It is the first confirmation that the FDA’s own analysis of Avandia shows a similar magnitude of heart attack risks – dangers that were first publicly raised in a medical journal report published earlier this week.

Grassley complained that FDA higher-ups have said they want to wait for results of an ongoing study that will not be available for two more years before making a decision.

“That’s a long time from now when you have millions of Americans taking this drug,” said the statement by the Iowa Republican. “Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem.”

The FDA has been under fire since Monday’s report came out, attacked by consumer advocates for dropping the ball on drug safety and for taking no stronger action in light of the new warning signs.

Avandia, sold by the British company GlaxoSmithKline PLC, is a blockbuster medication used to treat Type 2 diabetes, the most common form of the disease. More than 6 million people worldwide have taken the drug, whose U.S. sales topped $2.2 billion last year.

The entire article can be read here.

And in the UK, what is the MHRA doing about this, I wonder?

Charities and their good works – continued

Well then – it seems that Bob Fiddaman over at Seroxat Sufferers has been in contact with some of the ‘movers and shakers’ behind the healthcare charities and grassroots patient groups that I find it so difficult to believe in – see my posts here, here, here and here.

There are two posts at Seroxat Sufferers detailing correspondence with Amelia Mustapha (ex Depression Alliance/Centre for Mental Health) and with Dr Chris Manning (Primhe).

I’ll leave you to read the posts and make up your own mind about what’s been said – but what I find strange is that ‘patient advocates’ can be so dismissive of campaigners like Bob Fiddaman and myself, while at the same rubbishing experts such as Professor David Healy, Richard Brook, Charles Medawar, Dr Peter Breggin, Dr Andrew Herxheimer, Paul Flynn MP and organisations such as MIND and Panorama.

Amelia, Jim and Chris seem unconcerned at the way drug companies operate – the way they bury data from clinical trials that are negative and twist words and statistics to wriggle out of any liability. Not one of the three of them seems to be interested in even considering the overall efficacy and safety profile of modern antidepressants.

They are keen however, to question the motives of anyone who takes a view that is not on-message with their own view. On this blog Jim has questioned my motives for writing. Well the answer is – I’ve taken Seroxat and I suffered greatly because of it, as did my family. I’m not going to let the drug companies get away with it if I can help it. Patients must be able to make informed consent about treatment and at the moment the MHRA and drug companies simply do not allow this.

I do not earn any money from this blog – this is not how I make my living. Amelia, Jim and Chris, on the other hand, are ‘professionals’ – who see no possible conflict of interest in taking funding from, and working with, the drug companies.

See this post here and this one here to learn about ‘astroturfing’.

Convenient honesty and Zoloft

I’ve taken this post from CL Psych – I haven’t re-written it in any way as the job has already been done and he’s done it so well.

I must say I’m amazed that drug companies such as Pfizer think they can get away with tactics like this.

Read on:

Recently, a study was published which cast doubt on the efficacy of sertraline (Zoloft) for PTSD, finding that the drug was no better than a placebo.

The kicker is that the patent has expired for Zoloft, which is why the data are now flowing more freely. I’ll make the case here that data were buried until they would no longer hurt sales to any meaningful extent, at which point data were published, at least partially as a public relations move to show just how “honest” the companies are with sharing both positive and negative results with the psychiatric community.

The Research: The latest study, which appears in the May 2007 Journal of Clinical Psychiatry, showed no benefit for drug over a 12-week period. Placebo tended to outperform Zoloft on the majority of outcome measures, though the differences were of a small and statistically insignificant degree. Patients were significantly more likely to drop out of treatment on Zoloft. It was unclear if there were any serious adverse events (e.g., suicide attempts, notable aggression, etc.) because the article did not mention them at all. Patients started this study between May 1994 and September 1996. The original draft of the study was received by the journal in March 2006. Nearly 10 years passed between study completion and writing up the data for publication.

Two prior studies found positive results found positive results for Zoloft and were published quickly, while these negative results languished until the Zoloft patent had expired. One earlier positive study did not list the dates during which the study occurred, but it seems clear that it was rushed to publication much quicker than the negative study. Another positive study was conducted between May 1996 and June 1997 and was published in 2000. It’s quite obvious why the positive studies were rushed to press and the negative study languished, is it not?

Do keep in mind that the magnitude of positive effect for Zoloft over placebo, even in the positive studies, was small to moderate. When even the positive news for antidepressants in treating PTSD show only modest improvement relative to placebo, one should tread cautiously.

Change of Heart: Drug companies have been criticized widely for failing to disclose clinical trial data (1, 2). In an effort to shore up the support of the medical community and the public at large, what could possibly make more sense than publishing negative trial results? Gee, look at how honest we are – we share the good news and the bad news! Of course, when the positive results are published as quickly as possible and the negative results are published after a 10 year delay, well after the negative results can pose any threat to corporate profits, I’m not impressed by their newfound dedication to transparency.

Note: If you are a journalist, this is the kind of story that would merit a broad audience. The plot is pretty simple to follow and it reeks of corporate malfeasance, a subject that is not new to Pfizer and its former cash cow antidepressant.

There was a comment on CL Psych’s blog about this post noting that “It’s also possible that “dissing” the old one [Zoloft] helps the sales of a newer (patented and therefore more profitable) alternative.”

So much for Pfizer and transparency.

What price honesty?

More on Glaxo and Avandia

This editorial from the New York Times:

Ignoring the Warnings, Again?
The latest findings on Avandia, a top-selling diabetes drug, raise concerns both about its safety and about the way the manufacturer and the Food and Drug Administration have responded to signs of danger. It would be rash to make definitive judgments until the F.D.A. completes a detailed analysis. But the handling of this case bears disturbing resemblances to the Vioxx debacle, in which early warning signs were ignored by its manufacturer until the evidence of serious harm became inescapable and the drug was pulled from the market.

Avandia was approved for sale in 1999 based on studies showing that it could lower blood glucose levels in patients suffering from Type 2 diabetes, also known as adult-onset diabetes. The assumption was that the drug could alleviate some of the most damaging effects of the disease, such as heart attacks and other cardiovascular ailments. But a paper just published in The New England Journal of Medicine suggests that Avandia may instead increase the risk of a heart attack by 43 percent and perhaps the risk of cardiovascular deaths as well.

The study — an analysis of the combined results of 42 previous studies that compared people who took the drug with people who did not — is not definitive, and the absolute risk to any given patient is small. But the study points to a risk that could potentially harm thousands of patients a year. Its lead author was Steven Nissen, a cardiologist at the Cleveland Clinic, who blew the whistle on the cardiovascular risks of Vioxx, which adds to the sense of déjà vu.

What’s most troubling is the possibility that early warning signs were not adequately heeded.

Seven years ago a leading diabetes doctor warned the F.D.A. of “a worrisome trend in cardiovascular deaths,” two years later a safety monitoring group within the agency expressed concern over cases of heart failure in patients taking the drug. In late 2005 and again in August 2006 the drug’s manufacturer — GlaxoSmithKline — informed the F.D.A. that its own combined analysis of various studies showed a 31 percent increase in adverse cardiovascular events. But the company also cited studies that it said showed no evidence of harm, and the F.D.A. concluded the findings were too mixed to take immediate regulatory action.

Now, prodded by Dr. Nissen’s article, the agency has issued a safety alert, is completing its own safety analysis and will convene a panel of experts to review the data. The best hope for a definitive answer may lie in a clinical trial that won’t finish monitoring all enrolled patients until late next year.

If the verdict goes against Avandia, the F.D.A. and Glaxo will have a lot to explain. Congress will need to probe hard to determine what risks the agency and the manufacturer were aware of and what they did — or didn’t do — to mitigate them.

Catch up on Glaxo and Avandia here and here.

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